Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission After First-line Chemoradiotherapy

Exclusion Criteria

• •1. Patients with extensive SCLC (Appendix 2)；
• •2. The subjects are confirmed to have brain or meningeal metastasis before they are randomly divided into groups；
• •3. During the 5 years before the start of the study, patients with malignant tumors other than SCLC, diseases with negligible risk of metastasis or death (such as expected 5-year OS \> 90%) and malignant tumors expected to be cured (such as fully treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated by curable surgery, ductal carcinoma in situ treated by curable surgery)；
• •4. Previous head and neck radiation fields overlapped with PCI field；
• •5. MRI examination contraindicated
• •6. There is evidence that significantly uncontrolled concomitant disease may affect the compliance of the study program, including severe liver disease (such as liver cirrhosis), uncontrollable major seizures or superior vena cava syndrome；
• •7. Major cardiovascular diseases, myocardial infarction or cerebrovascular events within 3 months before randomization, unstable arrhythmias, or unstable angina pectoris；
• •--Patients with known coronary artery disease, congestive heart failure that do not meet the above criteria, or left ventricular ejection fraction ((LVEF)) \< 50% must receive a stable treatment plan and optimize it according to the advice of the attending physician, and consult a cardiologist if necessary。
• •8. Stroke (including hemorrhagic and ischemic) or transient ischemic attack occurred within 6 months before enrollment；
• •9. There were clinically significant bleeding symptoms or obvious bleeding tendency within 1 month before entering the group, such as gastrointestinal bleeding, gastric ulcer bleeding, active hemoptysis or vasculitis；
• •10. Serious arteriovenous thrombosis events occurred within 3 months before enrollment, such as deep venous thrombosis, pulmonary embolism, etc. (except for implantable venous infusion port, catheter-derived thrombosis or superficial venous thrombosis, these conditions are not considered "severe" thromboembolism);
• •11. Diabetic ketoacidosis or hyperglycemia and hyperosmosis occurred in the past 6 months;
• •12. There was a history of hypertensive crisis and hypertensive encephalopathy;
• •13. Any other disease, metabolic disorder, abnormal result of physical examination or laboratory examination, and there is reason to suspect that it may affect the reliability of the results of the study or put the patient at high risk of treatment complications；
• •14. The results of HIV test is positive
• •--All patients must be tested for HIV; patients with positive results of HIV will be excluded.
• •15. Major surgery has been performed within 28 days before the start of the study treatment, or major surgery is expected to be performed during the study period (except those for diagnostic purposes)；
• •16. Severe infections occur at the beginning of the study, including, but not limited to, infectious complications requiring hospitalization, bacteremia, or severe pneumonia；
• •17. Pregnant or lactating women；
• •18. Previous history of severe neurological or mental disorders, including epilepsy, dementia or severe depression that interfere with assessment;
• •19. The researchers believe that some conditions of the patients may affect the evaluation of the efficacy of this study, as well as the compliance of patients with this study.